Life Sciences Panel: Decision Analysis and Medical Benefit-Risk Decision Making with the FDA

Grays Peak

Pharmaceutical industry and regulators use decision analysis within their organizations to support complex benefit risk decision-making.  Systematic use of quantitative benefit risk assessment is possible in future interactions between these stakeholders.  Regulators are exploring ways in which quantitative decision analysis approaches, methods and tools can be used to inform benefit risk assessment and decision making in both premarket and post market settings.  This panel will discuss practical challenges and explore opportunities to address them to enable the appropriate application of decision analysis in complex benefit risk decision-making. What are the barriers and how can the DA community help?

Panel Chair: Robert F. Reynolds

Life Sciences